Biomarker Solutions
for Biotherapeutics

Biomarkers play an integral role in new drug development by providing valuable information to facilitate the decision-making process for new therapies. Biomarker-based stratification can be used to enrich clinical populations, reducing cost and trial duration. Drawing from years of experience as pioneers in the field of clinical biomarker science, Inotiv provides guidance to help you better understand what your data means for your program and how it can be applied to advance your therapeutic along its development pipeline.

Our scientists are experts in finding the optimum analytical strategy for biomarker detection analysis and data interpretation. Our method development and validation strategies are shaped by industry guidelines to provide you with the data needed to make informed decisions to advance your preclinical and clinical programs.

Support Across the Drug Development Continuum

Our bioanalytical team supports your program with biomarker development and translational research from preclinical discovery through clinical development.

Biomarker Strategy and Platforms

Inotiv has extensive experience designing preclinical and clinical biomarker strategies to support our clients’ broader clinical development objectives. Working collaboratively with you, we focus on carefully selecting biomarkers to deliver results that support your decision-making process.

Our specialized biomarker services include: 

• Advice on the optimal selection of biomarkers in the context of your drug candidate, target disease, and project budget
• Development, optimization, and validation of biomarker assays across a wide range of matrices and technology platforms
• Biomarker analysis of preclinical and clinical samples for exploratory or clinical trial settings
• Explanation/interpretation of results and counsel on key outcomes and decisions to be made about candidate therapies

Our biomarker strategies encompass the full biological spectrum, including DNA, RNA, protein, cell, and tissue analysis, matched with proven and trusted technology platforms, including: